Roberto Pisano

TL;DR: In this paper, an innovative and modular system (LyoMonitor) for monitoring the primary drying of a lyophilization process in vials is illustrated: it integrates some commercial devices (pressure gauges, moisture sensor and mass spectrometer), an innovative balance and a manometric temperature measurement system based on an improved algorithm (DPE) to estimate sublimating interface temperature and position, product temperature profile, heat and mass transfer coefficients.

TL;DR: The design space comprises those operating conditions that fulfill the operation constraints throughout primary drying, thus giving a much more conservative recipe when designing the process or potentially misleading results when analyzing process failures.

TL;DR: In this paper, the authors focused on the methods based on the pressure rise test (PRT) used to monitor the primary drying of a lyophilization process, and the optimal selection of the sampling frequency and the time interval between two tests was discussed, as well as the influence of the duration of the test on the results.

TL;DR: In this article, the effect of batch heterogeneity on the performance of the monitoring and control system is discussed and a new tool is presented, based on an advanced algorithm, that estimates the state of the system (product temperature and residual ice content) by using the results of the pressure rise test, coupled with a controller (LyoDriver) that changes the shelf temperature in order to maintain product temperature below the maximum al...

TL;DR: This study showed that inter-vial variability remains significant when vials are loaded on plastic trays, and how inter- vial variability can be taken into account during process design.